A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

January 13, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study

This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • the First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 18-55 years;
  2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
  3. Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
  4. Take contraception.

Exclusion Criteria:

  1. Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
  2. Severe infection, severe trauma or major surgery;
  3. Any medications in the two weeks before screening or baseline period;
  4. History of blood donation or severe blood loss;
  5. Have been vaccinated within 3 months before the screening or baseline period;
  6. History of smoking or excessive alcohol or drug abuse;
  7. History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
  8. Other situations in which the researcher judges unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-8080 Tablets and Itraconazole Capsules Group
Drug: HRS-8080 Tablet
HRS-8080 tablet, specified dose on specified days.
Drug: Itraconazole Capsule
Itraconazole capsule, specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to maximum plasma concentration (Tmax) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Terminal elimination half-life (t1/2) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Apparent volume of distribution (Vz/F) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Clearance (CL/F) of HRS-8080.
Time Frame: From Day 1 to Day 11.
From Day 1 to Day 11.
Adverse events (AEs).
Time Frame: From Day 1 to Day 17.
From Day 1 to Day 17.
Serious adverse events (SAEs).
Time Frame: From Day 1 to Day 17.
From Day 1 to Day 17.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-8080-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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